COFEPRIS Releases 34 New Medications

On Dec. 18, 2017, COFEPRIS announced the approval of 34 innovative medicines for their sale in Mexico. These medications address a vast number of sicknesses affecting the Mexican population, ranging from extremely common diseases, such as diabetes, to rare diseases.

Over the course of the next four weeks, we will publish a short summary on key samples of these medications grouping them by the medical area they target, with the aim of giving a glimpse of the health priorities currently being addressed by regulators.

Oncology

A cancer diagnosis is still one of the most terrifying things to hear at a doctor’s office. In Mexico, cancer is the third most common cause of death. About 148,000 new cases are diagnosed every year and this number is expected to rise to over 220,000 per year by 2025.

The battle against cancer continues to rage on, with unmeasurable time and money spent globally in the search of a cure or, more specifically, a treatment for every specific type of cancer. The drugs recently approved by COFEPRIS treat certain forms of melanoma, breast cancer, leukemia and other types of cancer.

Cotellic, treatment of melanoma

More sun exposure, increased use of tanning beds and an aging population are steadily increasing the rate of melanoma worldwide. This type of skin cancer is the 10th most common type of cancer in the world and is among the deadliest, as it kills 50 percent of those diagnosed. The FDA states that Cotellic (cobimetinib) prevents and slows down cancer cell growth and thus approved it for the treatment of advanced metastatic melanoma with BRAF V600E or V600K gene mutation.

Kisqali, treatment of breast cancer

Breast cancer holds the dubious honor of being the major cause of death among women aged 25 and older, with 458,000 deaths and 1.38 million new cases per year globally. Breast cancer comes in different types, which in turn require different and sometimes quite specific treatments. Kisqali (ribociclib) is an inhibitor of cyclin-dependent kinase (CDK) 6, which promotes cell division in cells. Some cancerous cells show increased CDK activity, which might inactivate antioncogenes, the tumor suppressor genes that protect cells from cancer. Kisqali is used in combination with an aromatase inhibitor to treat human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal women.

Oncaspar, treatment of lymphoblastic leukemia

Oncaspar (pegaspargase) was approved by the FDA on July 24, 2006 for the treatment of acute lymphoblastic leukemia (ALL), one of the most common types of leukemia in children. Mexico has the largest number of cases of leukemia in Latin America. ALL is a malignant blood cancer where lymphocytes are unable to mature and replace other marrow elements, thus reducing the production of normal blood cells. L-asparginase, another antileukemia drug that reduces serum asparagine is a common treatment for this cancer but some patients present hypersensitivity to it. Oncaspar is a good replacement drug for patients who are hypersensitive to L-asparginase.

Rigetuxer, treatment of several cancers and immune diseases

Rigetuxer (Rituximab) is a monoclonal antibody that kills normal and malignant B cells, which are white blood cells essential to the immune system. For that reason, rituximab is used for a broad variety of maladies that affect B cells, including several immune diseases and cancers such as Hodgkin’s lymphoma, rheumatoid arthritis, Wegener granulomatosis and chronic lymphocytic leukemia. This medication also has designations as an orphan drug for the treatment of immune thrombocytopenic purpura and pemphigus vulgaris.